Kornimate/medical-research-clean huggingface dataset:
effectiveness and toxicity of gemcitabine/lobaplatin versus gemcitabine/cisplatin as second-line treatment in metastatic breast cancer

Conditions: Breast Cancer

Summary: gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. the purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic breast cancer * disease progression during or after previous 1st line chemotherapy * scheduled to receive 2nd line chemotherapy. * measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension * 18 years of age or older * ecog performance status of 0-2 * life expectancy of greater than 6 months exclusion criteria: * previous treatment with one of the study drugs * application of other cytotoxic chemotherapy or radiotherapy * insufficent renal function (creatinine clearance \< 60ml/min) * clinically unstable brain metastasis * pregancy or lactation * history of other malignancy within last 5 years.

Keywords: breast cancer gemcitabine lobaplatin cisplatin
ultrasonic measurements of the clitoris in fetuses

Conditions: Ambiguous Genitalia

Summary: abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. to the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. the purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.


Eligibility criteria:
inclusion criteria: * well dated pregnancy * singleton pregnancy * female fetus * appropriate for gestational age exclusion criteria: * small for gestational age * other fetal anomalies * maternal conditions that can cause exposure of the fetus to high androgen environment

Keywords: clitoris
erector spinae plane block and its impact on postoperative diaphragmatic dysfunction in morbidly obese patients undergoing laparoscopic sleeve gastrectomy

Conditions: Diaphragmatic Dysfunction

Summary: postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients

investigators aimed to evaluate the impact of erector spinae plane block on the incidence of postoperative diaphragmatic dysfunction in morbidly obese patients (body mass index more than or equal 40)

Eligibility criteria:
inclusion criteria: * morbidly obese (body mass index\> 40) * undergoing sleeve gastrectomy exclusion criteria: * allergy to bupivacaine * respiratory comorbidities * preoperative diaphragmatic dysfunction * patient refusal * inability to adequately visualize diaphragm

Keywords: erector spinae block diaphragmatic dysfunction morbidly obese
effect of csii and cgm on progression of late diabetic complications

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (cgm) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes

80 type 1 diabetic patients with kidney function (gfr \> 45 ml/min), but with urine albumin excretion of at least 30 mg/day and hba1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (cgm) (intervention group). patients must be in stable raas blockade before entering the study. before the study is initiated all patients receive education in intensive diabetes treatment and self-care including carbohydrate counting. patients return to the clinic after 1,3,6,9, and 12 months for measurement of urine albumine excretion, clinical examination including blood pressure, cgm sensor readings, four-point self monitored blood glucose (smbg) profiles, blood samples and fulfillment of questionnaire to assess quality of life. at entry and after 12 months, eye fundus foto, 24-hour blood pressure, gfr, and carotis intima media thickness (cimt)are also evaluated.

Eligibility criteria:
inclusion criteria: * 18-75 years of age, * type 1 diabetes according to who criteria, * urin albumine \> 30 mg/g (albumine/creatinine ratio), * hba1c \> 7.5 \< 13.0%, * no change in raas blocking treatment at least 4 weeks prior to screening. exclusion criteria: * kidney disease other that diabetic nephropathy, * recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator, * use of insulin pump within 12 months, * acute myocardial infarction within 3 months, * severe arteriosclerosis as judged by the investigator, * heart failure (nyha class 3 or 4), * abuse of alcohol or drugs, * any cancer diagnosis unless in remission at least 5 years prior to screening, * participation in other intervention studies, * pregnant or lactating women, * any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.

Keywords: type 1 diabetes mellitus albuminuria late diabetes complications csii cgm glycaemic control
family centered intervention after traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, the traumatic brain injury family system intervention (tbifsi), for the family members and tbi patients in improving family dynamics and functioning. the intervention will be provided in collaboration with the municipal rehabilitation service. the intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by oslo university hospital (ouh).


Eligibility criteria:
inclusion criteria: patients: home dwelling individuals age 16-65 who have sustained a tbi and receiving health services. they should: 1. be out of post traumatic amnesia for at least one month 2. have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months 3. have a ranchos los amigos scale score of at least 8 4. mini mental status examination score \>23 * family members: individuals related by blood or marriage/cohabitating with the tbi patient. 1. belongs to the same household as the individual with tbi and/or in close relation with the patient 2. are between 18-65 years of age. exclusion criteria: * tbi survivors or their family members with a history of psychiatric or neurologic illness, active learning disability, or active substance abuse. inability to speak and read norwegian. families in which there are other members requiring care or who have previously been caregivers for other family members.
evaluation of cortisone treatment in children with acute facial nerve palsy

Conditions: Facial Palsy; Facial Nerve Diseases; Borrelia Infection of Central Nervous System; Bell Palsy

Summary: acute facial nerve palsy occur in 10-20/100 000 children/year in sweden. about 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children. investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. participants will be recruited consecutively at 9-12 study centers in sweden during 2019-2020. oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. clinical data, including recovery will be followed-up until 12 months. the primary outcome is defined as total recovery of the facial nerve palsy, measured with the house-brackmann scale (grade 1) at 12-months follow-up. the overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. if the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.


Eligibility criteria:
inclusion criteria: 1. 1-17 years of age 2. acute peripheral unilateral facial nerve palsy 3. less than 72 hours since debut of symptoms 4. signed informed consent exclusion criteria: 1. head trauma \<1 month 2. central or bilateral facial nerve palsy 3. malformations in head and neck 4. conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose) 5. current or past oncological diagnosis 6. other serious medical conditions (meningitis, encephalitis, stroke) 7. acute otitis media 8. signs of herpes simplex or varicella zoster infection (vesicles in the ear region) 9. pregnancy or breastfeeding 10. use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms 11. immunization with live vaccine 1 month prior onset of symptoms 12. requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo) 13. evaluation of primary endpoint at 12 months not feasible for any reason 14. previously included into the face study

Keywords: children paediatric
anthocyanin-rich table grape powder for prophylaxis of post-operative atrial fibrillation

Conditions: Post-operative Atrial Fibrillation (POAF)

Summary: postoperative atrial fibrillation (poaf) is a common complication following cardiac surgery and leads to worse outcomes. poaf is thought to be caused by the inflammatory state following cardiac surgery. it may be that anti-inflammatory medications could lower the occurrence of poaf, however many typical anti-inflammatory medications, such as ibuprofen, are contraindicated in the post cardiac surgery patient due to increased risks of bleeding. if a drug was identified with anti-inflammatory properties with minimal deleterious side effects, this could be broadly applied to cardiac surgery patients for the prevention of poaf. interestingly, several small trials have shown that medications that alter transcription of inflammatory markers lead to decreased poaf. furthermore, we have shown that phytochemicals, such as those found in grapes, have excellent bioavailability and can affect cardiac gene transcription related to inflammation. in this study, we propose to evaluate the efficacy of preoperative administration of concentrated grape powder in the prevention of poaf.


Eligibility criteria:
inclusion criteria: * males and female patients (age 50-79) at the mitral valve clinic/cvc undergoing elective cardiac surgery for mitral valve repair without the cox maze procedure (mvr patients also undergoing cabg and/or tricuspid valve repair are also eligible) * in sinus rhythm (no pre-operative atrial fibrillation) exclusion criteria: * age ≥ 80 years * diagnosed pre-operative chronic or paroxysmal af * prior ablation procedure for af * previous cardiac surgery * implanted pacemaker * active smoker * comorbidities such as congenital or cardiac re-operation * use of antiarrhythmic agents * active inflammatory or infectious disease or malignancy * diagnosed autoimmune disease * corticosteroid or other immunomodulatory or immunosuppressive medication * risk factors for poaf including low ejection fraction (ef) (ef\ 5.0 cm), and high degree of mitral regurgitation (grade 3-4).
local injection of periodontal pocket method for the treatment of gingivitis

Conditions: Periodontitis

Summary: preliminary clinical studies have confirmed that injection of freshly prepared ha35 can reduce symptoms and signs of gingivitis or periodontitis. this clinical study is a prospective repeated experiments. the purpose of this study was to verify the effectiveness of ha35 injection therapy.

the previous studies showed that toothpastes containing the cosmetic grade raw material of the 35 kda low molecular hyaluronan fragment ha35 significantly reduced symptoms and signs of gingivitis or periodontitis. in this study, patients with mild to moderate periodontitis suffering from symptoms and signs, including discomfort and swelling and bleeding of periodontal tissue, were treated by intrapocket injection of freshly manufactured hyaluronan fragment ha35. this study is an repeat clinical study comparing pre- and posttreatment effects similar to others.

Eligibility criteria:
inclusion criteria: * healthy condition and with a clinical diagnosis of mild to moderate gingivitis. * male or female volunteers aged 18-60 years. * gingival index (gi) from 1 to 2 (0= normal gingiva; 1= mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= moderate inflammation - redness, edema and glazing, bleeding on probing) exclusion criteria: * healthy condition and with a clinical diagnosis of severe gingivitis. * pregnant or lactating females. * be concomitantly participating in another clinical study. * history of any allergic reaction to ha. * to treat the gingivitis with any other medication/mouthwashes in the period of the study.
improving wisely - polypharmacy

Conditions: Adverse Drug Event

Summary: this is a randomized controlled trial that uses an audit and feedback intervention to alert primary care physicians who are outliers in one or more metrics related to high risk prescribing of participants' outlier status. primary care physicians will be randomized to the intervention or control arm, except in california, where all outliers will be notified. the investigators will evaluate the impact of the intervention on prescribing patterns.

the investigators have developed five different metrics related to low-value (and/or high risk) prescribing habits based on guidelines. the five metrics are listed below. the investigators are using 100% capture medicare claims data to evaluate the prescribing habits of all us primary care physicians who prescribed to ten or more medicare patients. a patient is attributed to the primary care physician who prescribed the patient the most medications that year. the investigators have calculated the mean, median, and standard deviation for each of the five metrics based on data from 2016. all primary care physicians who are two or more standard deviation above the mean of a given metric are considered outliers. in each state (excluding california), half of the outliers while be randomly assigned to the intervention group and half will be assigned to the control group, using a random number generator. those outliers who are assigned to the intervention group will receive a cover letter signed by a members from the physician engagement council (pec), which is composed of physicians from the society of general internal medicine (sgim) which explains the study. participants will also receive a report of participants' status as an outlier which shows in both text and graphic representation, how participants compare to participants' peers. these communications will be sent by mail. the control group will not receive any communication. all outliers in california will receive the intervention. brief summary of metrics: * metric 1: average number of concurrent medications per older patient, by physician * metric 2: proportion of older patients who received at least one medication that is a designated high-risk medication in older patients, by physician * metric 3: proportion of older patients with concurrent use of multiple central nervous system-active medications, by physician * metric 4: proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications, by physician * metric 5: proportion of older patients with concurrent use of opioids and benzodiazepines, by physician

Eligibility criteria:
inclusion criteria: * primary care physician * must be the primary care physician for at least ten medicare patients exclusion criteria: * none
peritoneal surface malignancies - characterization, models and treatment strategies

Conditions: Pseudomyxoma Peritonei; Colorectal Carcinoma; Ovarian Carcinoma; Mesothelioma

Summary: the aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (crs) with hyperthermic intraperitoneal chemotherapy (hipec), and through animal models to explore different treatment strategies for peritoneal surface malignancies (psm).

the handling of patients with psm involves multimodal and multidisciplinary treatment strategies such as crs, the removal of all macroscopically detectable tumor, and hipec, instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease. the treatment is challenging and complex and associated with significant morbidity. only patients with limited disease will benefit from the treatment, and better methods for patient selection are needed. the project group has a unique opportunity to address key questions because of acquired experience, an exceptional biobank and institutional database and novel animal models established at the norwegian radium hospital.

Eligibility criteria:
inclusion criteria: * age \> 18 years * confirmed diagnosis of peritoneal surface malignancy * candidate for crs-hipec * written informed consent exclusion criteria: * none approximately 80 patients per year will be eligible for inclusion, as this is the number of patients that annually receive surgical treatment for psm.

Keywords: peritoneal carcinomatosis peritoneal surface malignancy cytoreductive surgery hyperthermic intraperitoneal chemotherapy crs hipec prognostic biomarker predictive biomarker
physical activity and sports for people with visual impairments

Conditions: Blindness; Visual Impairment

Summary: purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination.

the participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. all participants legal guardians, were given the written informed consent form after the detailed written explanation of the risk and benefits resulting from participation in this study. static balance was assessed using the portable accusway-optimized (acs-o) by amti stabilographic platform (acs model). the study participants performed the both feet 30 second, single 10 second left and right-leg stance with eyes open (eo), and both feet 30 second, left and right-leg stance with eyes closed (ec). if the first attempt was not successful, study participants were able to do the second attempt. the tests were conducted approximately 2 hours after a meal, in a sports outfit, in a specially designated room. the functional assessment of locomotor skills will utilize the "locomotion" subtest, which is part of the test of gross motor development, second edition (tgmd-3) battery. in the selected "locomotion" subtest, the following movement tasks (locomotor skills) are assessed: run, gallop, hop, horizontal jump, skip, slide. the subtest 4 "bilateral coordination" of the bruininks-oseretsky test of motor proficiency (bot-2) was used in this study. the bot-2 is an individually administered test that includes goal-directed activities to measure a wide range of motor skills in individuals aged 4 to 21 years. participants performed seven items: 1. touching nose with index fingers - eyes closed 2. jumping jacks 3. jumping in place - same sides synchronized 4. jumping in place - opposite sides 5. pivoting thumbs and index fingers 6. tapping feet and fingers - same sides synchronized 7. tapping feet and fingers - opposite sides

Eligibility criteria:
inclusion criteria: * written consent form, * visual impairment (diagnosed) * intellectual norm. exclusion criteria: * nervous system disorders, * structural changes within the musculoskeletal system * and intellectual limitations.

Keywords: balance fundamental motor skills bilateral coordination visual impairments
smart trainer arm ergometry exercise training in individuals post-stroke

Conditions: Stroke

Summary: the smart trainer ergometer is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways. the purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals with post-stroke limb impairment.

individuals with physical disabilities show much lower rates of exercise participation than their able-bodied peers. much of the reason for the low rates of activity among this population comes from the presence of barriers. lack of motivation, lack of transportation, lack of accessible facilities and equipment, and cost are all factors that discourage exercise participation among those with disabilities. based on these factors, there is a need for accessible enjoyable exercise options for people with physical disabilities. the smart trainer ergometer (also known as the advanced virtual exercise environment device) is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways. in our previous protocol (irb-300001384) we explored the power output curves of people post stroke compared with non-impaired individuals during one arm versus two arm cycling exercise using the smart trainer arm ergometer. the work demonstrated the potential benefit of interactive exercise for those with physical disabilities. the purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals who have a stroke-based limb impairment.

Eligibility criteria:
inclusion criteria: * males and females post-stroke * age 40-70 years * able to use both arms during arm cycling exercise (i.e., able to complete the 10 revolution pre-test) exclusion criteria: * younger than 40 and older than 70 years * no movement in one arm or have an injury that prevents safe use of one arm during exercise * unable to complete the 10 revolution pre-test * unstable cardiovascular conditions * unable to understand study directions

Keywords: exercise arm ergometer virtual environment disability